Expanded Access to Veliparib

• Conditions: Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound; Triple Negative Breast Cancer (TNBC); High Grade Serous Ovarian Cancer; Patients Requiring Veliparib Suspension Formulation

• Registration Number: NCT03123211
• Lead Sponsor: AbbVie

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to veliparib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. EAP is also available for other indications where there is reasonable scientific basis for efficacy.

Detailed Description

Expanded Access

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• The patient has relapsed/refractory disease and exhausted all standard treatments.
• The patient has documented Breast Cancer (BRCA), BRCA associated RING domain (BARD), or Partner and Localizer of Breast Cancer (PALB) or other acceptable deoxyribonucleic acid (DNA) mutations.

Exclusion Criteria

• The patient is eligible for a Poly Adenosine diphosphate ribose polymerase (PARP) inhibitor clinical trial.
• The patient has previously received a PARP inhibitor for the same disease.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified